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Expert opinion

Safety of surgical meshes used in urogynaecological surgery

Final Opinion

Description

SCENIHR WG on Surgical meshes
SCENIHR members: Philippe Hartemann (chair), Theodoros Samaras (co-rapporteur), Luis Martínez Martínez, Norbert Leitgeb
External experts: Christopher Chapple (rapporteur), Fred Milani, Xavier Deffieux, Jorge Garcia, Catherine Brogan
Contact:SANCO-C2-SCENIHR@ec.europa.eu
On request from: European Commission
Doi:
Adopted on: 3 December 2015

Content of the opinion:

Surgical meshes have been used since the 1990’s for the treatment of male and female stress urinary incontinence (SUI), female pelvic organ prolapse (POP) and colorectal functional disorders (CFD). More recently the use of synthetic mesh and biological materials has become common requiring new surgical insertion tools and tissue fixation anchors.

The use of meshes in surgery has been shown to be associated with various adverse effects such as infection, tissue extrusion, separation of vaginal epithelium leading to mesh exposure, mesh shrinkage and adverse side effects including pain and sexual dysfunction. The European Commission has thus requested the SCENIHR to assess the health risks of meshes used in urogynaecological surgery.

The various options for the treatment of pelvic floor dysfunctions were reviewed based on the scientific literature and the guidelines from scientific societies and health authorities. Included were both non-surgical and surgical treatment methods.

In assessing the risk associated with mesh application, the SCENIHR calls attention to consider the overall surface area of material used, the product design and the properties of the material used. The available evidence suggests a higher morbidity in treating POP, which uses a much larger amount of mesh compared to SUI.

The implantation of any mesh for the treatment of POP via the vaginal route should be only considered in complex cases in particular after failed primary repair surgery. The use of autologous graft material is not feasible for POP because of the large mesh area required and the resulting donor morbidity. The use of absorbable mesh inserted either via a transabdominal or transvaginal route is associated with a high failure rate. Transvaginal surgery using non-absorbable synthetic mesh for POP involves a much greater surface area of mesh and is associated with a higher risk of mesh-related morbidity than seen with trans-abdominal insertion of this mesh. Sacrocolpopexy is associated with greater surgical morbidity.

Based on the available scientific evidence, SCENIHR’s recommendations include:

- Material properties, product design, overall mesh size, route of implantation, patient characteristics, associated procedures (e.g. hysterectomy) and surgeon’s experience are aspects to consider when choosing appropriate therapy.

- For all procedures, the amount of mesh should be limited where possible.

- The implantation of any mesh for the treatment of POP via the vaginal route should be only considered in complex cases in particular after failed primary repair surgery.

- A certification system for surgeons should be introduced based on existing international guidelines and established in cooperation with the relevant European Surgical Associations.

- Appropriate patient selection and counselling, which is of paramount importance for the optimal outcome for all surgical procedures. Patient selection and counselling should be based on the results of further clinical evidence, which should be collected in a systematic fashion for all of these devices.

Keywords:

SCENIHR, scientific opinion, risk assessment, surgical meshes

Opinion to be cited as:

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), The safety of surgical meshes used in urogynecological surgery, 3 December 2015.

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